Evaluation ctDNA in Patients of Non-Small-Cell Lung Cancer Following Resection

Sun Yat-sen University132 enrolled

Overview

Circulating tumor DNA (ctDNA) is a promising biomarker for noninvasive assessment of cancer burden. In this study, PEAC (Personalized Analysis of Cancer) technology was performed to detect the driver gene mutations from plasma samples and matched tumor tissue samples were detected by NGS platform at baseline. Investigators also applied ctDNA dynamic monitoring using PEAC technology in early stage NSCLC patients with driver mutations positive at baseline, to evaluate the feasibility and their potential clinical application.

Circulating tumor DNA (ctDNA) is a promising biomarker for noninvasive assessment of cancer burden. Advances in DNA sequencing technologies and our understanding of the molecular biology of tumours have resulted in increased interest in exploiting ctDNA as a tool to facilitate earlier detection of cancer and thereby improve therapeutic outcomes by enabling early intervention. In this study, PEAC (Personalized Analysis of Cancer) technology was performed to detect the driver gene mutations from plasma samples and matched tumor tissue samples were detected by NGS platform at baseline. Investigators aim to evaluate whether driver gene mutations detected by PEAC can replace tissue testing results in patients with stage I to Ⅲ NSCLC. Investigators also applied ctDNA dynamic monitoring using PEAC technology in early stage NSCLC patients with driver mutations positive at baseline, to evaluate the feasibility and their potential clinical application.

Study Type

OBSERVATIONAL

Enrollment

132

Conditions

Non-Small Cell Lung Cancer

Interventions

Perioperative ctDNA Dynamic MonitoringDIAGNOSTIC_TEST

To apply ctDNA dynamic monitoring in early stage NSCLC patients with driver mutations positive at baseline

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Postoperative histopathological diagnosis of TNM stage I to III NSCLC with R0 resection; * No adjuvant chemotherapy, radiotherapy, targeted drug therapy or biotherapy after surgery; * Men or women of age ≥18 years and \<75 years old; * Eastern Cooperative Oncology Group (ECOG) behavior status score 0 to 1. Exclusion Criteria: * Patients with other cancers other than NSCLC within five years prior to this study; * Who can not get enough tumor histological specimens (non-cytological) for analysis; * Human immunodeficiency virus (HIV) infection; * NSCLC mixed with patients with small cell lung cancer; * Pregnant or lactating women; * There is a clear history of neurological or mental disorders, including epilepsy or dementia; * Conditions that investigators think is not suitable for inclusion.

Locations (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

Concordance between genomic alterations assessed by next-generation sequencing in tumor tissue and PEAC technology in circulating tumor DNA

PEAC (Personalized Analysis of Cancer) technology was performed to detect the driver gene mutations from plasma samples and matched tumor tissue samples were detected by NGS platform at baseline.

Time frame: 2 years after the last patient enrolled

ctDNA dynamic monitoring

PEAC technology was performed to apply ctDNA dynamic monitoring in early stage NSCLC patients with driver mutations positive at baseline

Time frame: 2 years after the last patient enrolled

Data from ClinicalTrials.gov

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